Concerned By Confusion Over OTC Drug Brands, US FDA Offers Guidance On Developing Names
Extending an OTC brand name to a product with a different active ingredient and indication creates a margin for error in the marketplace, FDA says. Recommendations include best practices to help minimize name-related medication errors and a framework FDA uses in evaluating proposed propriety names.
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US FDA final guidance describes possible study design to test whether selected names may misbrand a drug. Agency also okays use of two-letter USAN stems in product names and clarifies use of modifiers.
US FDA encourages firms to “identify and avoid potential problems before the product is marketed” by comparing proposed names against the agency’s best practices recommendations and seeking the agency’s input.